RESUMEN
The prompt introduction of supportive care for patients with cancer leads to a better quality of life, potential survival benefits, and improvements in treatment safety. Considering that patients' needs vary, descriptive assessments could serve as a compass for an efficient and prompt healthcare response. The aim of this study was to identify supportive care needs in newly diagnosed patients according to cancer type. A retrospective study was conducted by collecting data from the case consultation and medical records of a comprehensive cancer center in France. Patients' needs were divided into twelve domains: nutrition, psychological support, psychiatric support, social care, physiotherapy, addictology, pain management, palliative care, pharmacology, complementary and alternative practice (CAM), sexual health, and speech therapy. Out of 6217 newly diagnosed patients of various cancer types who sought medical care at Gustave Roussy in 2021, 2541 (41%) required supportive cancer care (SCC), and of them, 1331 patients (52%) required two or more different SCC specialist interventions. The top five interventions were dietary (for 60% of patients), physiotherapy (33%), psychology (29%), social care (28%), and pain management (16%). Subgroup analysis according to cancer department highlighted additional specific needs: CAM for breast cancer patients (11%), speech specialist (27%) and addictologist (22%) interventions for ENT patients, psychiatry consultations for neurological patients (16%), and palliative care for dermatology patients (23%). The aforementioned data suggest that an early, multidisciplinary supportive care intervention should be required. Assembling human resources at the time of diagnosis within a dedicated day unit would be the next appropriate step in developing personalized care pathways related to the highlighted needs.
RESUMEN
Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.
Asunto(s)
Industria Farmacéutica , Farmacovigilancia , Consenso , Humanos , Seguridad del Paciente , Organización Mundial de la SaludRESUMEN
Increased intra-abdominal pressure (IAP) is associated with a variety of clinical situations and has profound effects, both locally and systemically, that may result in organ dysfunction and failure. If not identified and treated promptly, increased IAP can be fatal. Urinary bladder pressure monitoring is a simple and reliable method of quantifying IAP and is a key factor leading to prompt management and a successful outcome for patients.